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Ready for 50s next week then the fun starts. She's
Gonna be huge
forming new base...the 30's are the new 20's Can't touch this chart!!
pit stop
And another insider buy. Follow the money
More insider buying.
PUMA bidding...NITE and CDEL stacking....classic!
time to cool off
RZLT looks like .44c is setting up!!
CDEL controls the pace...trimmed some up here!!
Lmao at the 100k wall that was at .34 earlier, where’d it go??
NEWS and thin to 40c...lets rock!!!
RZLT chart is saying 41c next week!!
RZLT next week the weekly will be in order to ignite the move to .39C
RZLT gearing up for next week, nice and steady!!! Games games games!!
No games no gains
I've never seen so many games in my life on a ticker!!
big things ahead here
RZLT MORE INSIDE BUYING!!! HERE COMES THE 32C BREAKOUT!!!
games...the weekly needs 2 to 3 days to set off the trigger....39c coming!!
PATIENCE WILL PAY HUGE!!
they're creeping down hmmmmmmm
VNDM has been pushing the bid and sitting at .47c...PUMA lingering around top create fear!
RZLT ready to break out on the weekly side as we head to .38c
oh good, its a very special little stock!!
impressive
Jumped on this one a few days ago thanks TrendTrade !
RZLT here we go... MONSTER!!!! PAUL just ran for his life!!!! GTSM has nothing...PUMA in for the block!! VNDM bluffing...hes been on the bid all week, but retail has been up bidding him!!
RZLT accumulations builds...PAUL lingering around...he has nothing!! We slowly make our way through the fog!! It's gonna get crazy very soon!!
RZLT, over 1 000 000 shares bought directly this week by HANDOK, INC
RZLT chart is sick, every indicator showing strength. MASS TSI COPP TRIX AROON OBV ACC/DIST MFI ChiOsc ULT FORCE...anyone short here must be nervous.
RZLT trigger at 28c, thats coming fast$ Then all hell breaks outs!!
Rezolute has completed a successful pre-IND meeting with the FDA and IND-enabling toxicology studies in preparation for a Phase 1 study of RZ402 in DME. The exact timing of IND filing and study initiation is currently unknown due to the ongoing COVID-19 pandemic.
This therapy is most likely the one that is so important, because of it's nature with new born babies.
Congenital hyperinsulinism (HI) is an ultra-rare pediatric genetic disorder characterized by excessive production of insulin by the pancreas.
the connection...Handok CEO Kim Young-jin said, "Rezolute is a biotech company with great potential for growth, and there are many areas where it can cooperate with Handok and Genexine. In particular, its experience in the development of growth hormones will be highly helpful in accelerating the global phase 3 clinical trials on long-acting growth hormone GX-H9, which is being jointly developed Handok and Genexine."
https://clinicaltrials.gov/ct2/show/NCT03309891
RZLT has a treatment for diabetic macular edema, the treatments out there are not fun, a needle in your eye. These guys are testing animals now, and getting great results. This is not your average OTC biotech stock. this could move to the NASDAQ. CEO is a player!!!
RZLT heavy insider buying in the last week, this stock is ready to fly.
remember this....let the games begin.https://sec.report/Document/0001104659-20-041173/...
RZLT~~.09,HUGE NEWS~~Rezolute Receives Rare Pediatric Disease Designation for RZ358, Phase 2b Candidate for the Treatment of Congenital Hyperinsulinism, Enabling Eligibility for Priority Review Voucher
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June 10, 2020 08:30 ET | Source: Rezolute, Inc.
REDWOOD CITY, Calif., June 10, 2020 (GLOBE NEWSWIRE) -- Rezolute, Inc. (“Rezolute” or “the Company”) (OCTQB:RZLT), today announced that the company has received rare pediatric disease designation (RPD) from the Food and Drug Administration (FDA) for RZ358, a potential treatment for congenital hyperinsulinism (HI) that is currently being evaluated in a global Phase 2b study.
According to an FDA Guidance for Industry document (July 2019) concerning the incentive program for rare pediatric diseases, Rezolute now qualifies to be eligible for a Rare Pediatric Disease Priority Review Voucher as the sponsor of RZ358. Following an approval of RZ358 for congenital HI in pediatrics, such a voucher could be redeemed to receive a priority review of a subsequent marketing application.
“If we are successful at obtaining final approval for RZ358, we may obtain a valuable and transferable priority review designation for any subsequent marketing application that Rezolute could choose to utilize in the best interest of its shareholders,” said Nevan Elam, J.D., chief executive officer of Rezolute. “As there is currently no approved therapy with a label indication specifically for congenital hyperinsulinism, patients typically rely on treatments that are not optimal for the disorder. As a result, patients often experience serious side effects or limited drug efficacy. RZ358 is designed to restore healthy levels of insulin action in congenital HI for patients of any age – including children.”
RZ358 is a monoclonal antibody designed specifically to address congenital HI, an ultra-rare genetic endocrine disorder that appears in 1 in 25,000 to 1 in 50,000 live births in many populations. Congenital HI is characterized by excess insulin secretion, which causes repeated episodes of low blood sugar, or hypoglycemia. The condition often goes unnoticed in infants, putting them at risk of complications of recurring hypoglycemic events, including developmental delays, seizures, coma and death.
About Rezolute, Inc.
Rezolute is advancing targeted therapies for rare, metabolic, and life-threatening diseases. Its lead clinical asset, RZ358, is in Phase 2b development as a potential treatment for congenital hyperinsulinism, a rare pediatric endocrine disorder. Its pipeline also includes RZ402, an orally available plasma kallikrein inhibitor in late-stage preclinical development for the treatment of diabetic macular edema, which the Company intends to advance into clinical trials after the IND has been filed. For more information, visit www.rezolutebio.com or follow us on Twitter.
About Congenital Hyperinsulinism
Congenital hyperinsulinism (HI) is a rare, genetic, pediatric endocrine disorder that leads to the inappropriate secretion of the hormone insulin by the pancreas. High levels of insulin in the blood result in episodes of low blood sugar or hypoglycemia with associated suppression of ketone bodies, the only other potential source of fuel to the glucose-dependent brain. Repeat episodes and/or dangerously low blood sugars increase the risk of neurological and developmental complications, including persistent feeding problems, learning disabilities, recurrent seizures, and/or brain damage, or even death. Existing medical options were not developed for congenital HI and are often either ineffective since certain groups of patients do not respond to these therapies or are associated with substantial side effects that discourage compliance and lead to suboptimal treatment outcomes. Surgical removal of the pancreas is also an option, but this approach is invasive, may require repeat surgery, and ultimately leads to the development of lifelong insulin-dependent diabetes.
About RZ358
RZ358 is an intravenously administered human monoclonal antibody that binds with high potency and selectivity to an allosteric site on the insulin receptor. RZ358 counteracts the effects of elevated insulin at its target tissues by diminishing the binding and downstream signaling of insulin at its receptor. This unique mechanism of action gives properties of reversibility and graded activity, which are dependent on the extent of insulin elevation. Therefore, RZ358 is ideally suited as a potential therapy for hyperinsulinism, and it is being developed to treat the hypoglycemia associated with diseases such as congenital HI.
RZ358 received Orphan Drug Designation in the United States and European Union. Rezolute is currently evaluating RZ358 in the RIZE trial, a Phase 2b clinical trial in patients with congenital HI.
Forward-Looking Statements
This release, like many written and oral communications presented by Rezolute, Inc. and our authorized officers, may contain certain forward-looking statements regarding our prospective performance and strategies within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995, and are including this statement for purposes of said safe harbor provisions. Forward-looking statements, which are based on certain assumptions and describe future plans, strategies, and expectations of the Company, are generally identified by use of words such as "anticipate," "believe," "estimate," "expect," "intend," "plan," "project," "seek," "strive," "try," or future or conditional verbs such as "could," "may," "should," "will," "would," or similar expressions. Our ability to predict results or the actual effects of our plans or strategies is inherently uncertain. Accordingly, actual results may differ materially from anticipated results. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Except as required by applicable law or regulation, Rezolute undertakes no obligation to update these forward-looking statements to reflect events or circumstances that occur after the date on which such statements were made.
Media Contact
Amy Jobe, Ph.D.
LifeSci Communications
+1 315 879 8192
ajobe@lifescicomms.com
Investor Contact
Corey Davis, Ph.D.
LifeSci Advisors
+1 212 915 2577
cdavis@lifesciadvisors.com
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"AB101 has the potential to be a clearly differentiated product that represents a significant advance in basal insulin delivery," said Nevan Elam, AntriaBio's President and CEO. "AB101 may offer significant advantages over basal insulin products sold by Sanofi-Aventis and Novo Nordisk, which together sell more than $7B annually."
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